FDA/EMA Posts Conclusions of Parallel Assessment of Quality-By-Design Elements of Marketing Applications


Oct 01, 2013

In late August, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint question-and-answer document disclaimer icon that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of a marketing authorization application.

As part of this pilot program, U.S. and European regulators communicate and consult throughout the review process relevant to QbD aspects of the new drug and supplement applications. This parallel assessment aids sharing of regulatory decisions and facilitates the availability of consistent quality pharmaceutical products throughout the United States and the European Union.

Review the Q&A document here